This invention relates to a urinary incontinence device for alleviating female urinary incontinence. More specifically, this invention relates to a urinary incontinence device for alleviating female urinary incontinence during episodes of increased intra-abdominal pressure.
The primary etiological factor producing genuine stress urinary incontinence is the incomplete transmission of abdominal pressure to the proximal urethra due to displacement from its intra-abdominal position. Some women, especially women who have given birth to one or more children, and older women, can experience incidences of involuntary urine loss due to stress urinary incontinence or combined stress and urge incontinence. A sneeze or cough can increase the intra-abdominal pressure impinging on a person""s bladder thereby causing the involuntary release of urine. The frequency and severity of such urine loss can increase as the muscles and tissues, particularly near the urethro-vaginal myofascial area, grow weaker. It has also been recognized that the urinary sphincter muscle, which is located at the upper end of the urethra, adjacent to the bladder, works well at sealing off the passing of urine from the bladder to the urethra when it has a generally round or circular cross-sectional configuration. Support of the proximal urethra elevates it above the pelvic floor and subjects it to increases in intra-abdominal pressure, thus allowing compression and maintenance of continence. However, when this passageway becomes distorted into a cross-sectional configuration having more of an elliptical or oval appearance, the sphincter muscle can not close properly, therefore, the tendency for involuntary urine loss increases. One must remember that the urethra and vagina are not separate structures. Because of their common derivation from the urogenital sinus, they are fused in the distal two thirds of the urethra. In this region, they are bound together by the endopelvic connective tissue so that the support of the urethra depends not only on the attachments of the urethra itself to adjacent structures but also on the connection of the vagina and periurethral tissues to the pelvic wall.
As the world""s female population ages, there is an ever-increasing need for a non-surgical method or measure to reduce the involuntary urine loss commonly associated with stress urinary incontinence. Today, there are a number of specialized products available for this purpose. Most of these products can only be purchased with a prescription and they need to be properly sized, physically inserted and/or adjusted by a medical doctor or a nurse practitioner in order to perform correctly. Few, if any, products are commercially available in the United States, without a prescription, to prevent the involuntary urine loss associated with stress urinary incontinence.
In view of the lack of commercially available, non-prescription urinary incontinence prevention or mitigation devices, it is recognized that there is a need for a urinary incontinence device that can be purchased without a prescription. There is also a need for a urinary incontinence device that is uncomplicated and therefore more user friendly and can be managed by the consumer without the intervention of a medical practitioner. Furthermore, there is a need for a urinary incontinence device which is easy for women to insert into and remove from their bodies, be more comfortable to wear and provide psychological and realistic assurance that it is capable of properly performing over an extended period of time.
Briefly, this invention relates to a urinary incontinence device for alleviating female urinary incontinence. The urinary incontinence device includes a first absorbent and a second absorbent. The first absorbent has a width and a longitudinal axis. The second absorbent is positioned adjacent to the first absorbent and is aligned along the longitudinal axis. The second absorbent has a width that is less than about 80% of the width of the first absorbent. The first and second absorbents are formed into a softwind that is compressed into an elongated pledget having a cross-sectional area. The first and second absorbents are capable of absorbing fluid and expanding the cross-sectional area of the pledget. The second absorbent causes a portion of the cross-sectional area of the pledget to expand farther outward to provide a supportive backdrop for a woman""s urethra when inserted into a woman""s vagina.
The urinary incontinence device is inserted into a woman""s vagina with the insertion end entering first. The vagina has a vaginal canal with an inner periphery made up of right and left lateral walls, an anterior wall and a posterior wall. The urinary incontinence device is sized to contact at least two of the walls when inserted into the vagina. The urinary incontinence device is positioned in a middle third of the length of the vaginal canal with the insertion end aligned nearly adjacent to a woman""s urethral sphincter muscle, which is a part of a woman""s urethral tube. The urinary incontinence device cooperates with a woman""s symphysis pubis to compress the urethral tube therebetween. The urinary incontinence device is allowed to expand within the vaginal canal upon absorbing body fluid. As the urinary incontinence device expands, at least a portion of it increases in cross-sectional area and contacts all four interior walls of the vaginal canal and provides a supportive backdrop for the urethral tube. The urethral tube can then be compressed upon itself between the urinary incontinence device and the symphysis pubis thereby limiting involuntary urine flow.
The general object of this invention is to provide a urinary incontinence device for alleviating female urinary incontinence. More specifically, this invention relates to a urinary incontinence device for alleviating female urinary incontinence during episodes of increased intra-abdominal pressure.
A more specific object of this invention is to provide a urinary incontinence device that is placed in a woman""s vagina and allows for transmission of pressure sufficient to allow the urethra to collapse upon itself to prevent or mitigate involuntary urine loss commonly associated with stress urinary incontinence.
Another object of this invention is to provide a urinary incontinence device that is simple to use, easy to insert and remove, and which is comfortable to wear.
A further object of this invention is to provide a urinary incontinence device that can be manufactured and sold for a reasonable cost.
Still another object of this invention is to provide a urinary incontinence device that can be purchased by a consumer without a prescription.
Still further, an object of this invention is to provide a urinary incontinence device that does not disrupt the normal vaginal micro-flora which are necessary for a healthy vaginal environment.